Study of Tadalafil vs. Placebo for Improving Hemodynamics and End-Organ Dysfunction in Fontan Physiology

Mayo Clinic

Status and phase: Enrolling; Phase 3

Conditions: Fontan Palliation

Treatments: Drug: Tadalafil; Drug: Placebo

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05206955

R01HL160761-01 (U.S. NIH Grant/Contract)

21-009890

Details and patient eligibility

About

The purpose of this study is to find out more about the effectiveness of Tadalafil in improving hemodynamic capabilities, endothelial function, and end-organ function in patients who have previously undergone a Fontan Palliation.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients ≥ 18 years old.
• Have previously undergone a Fontan Palliation.
• Able to exercise using a supine bike.
• Ability and willingness to provide written consent.
• Undergoing a clinically indicated Cardiac Catheterization

Exclusion criteria

• Patients < 18 years old.
• Current intravenous inotropic drugs.
• Current use of alpha-blockers, pulmonary vasodilators, or nitrates.
• Unable to exercise.
• Pregnancy or lactating.
• Unable or unwilling to consent.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 2 patient groups, including a placebo group

Tadalafil Group

Experimental group

Description:

Study participants will receive 10 mg of Tadalafil daily for 1 week, then 20 mg daily for 1 week, and finally 40 mg daily for 50 weeks for a total therapy time of 52 weeks. Tadalafil will be taken orally in capsule form once daily.

Treatment:

Drug: Tadalafil

Placebo Group

Placebo Comparator group

Description:

Study participants will receive a placebo capsule that looks identical to the Tadalafil capsule. The placebo will be taken orally once daily for 52 weeks.

Treatment:

Drug: Placebo